Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

LNH 2018-03-20

Ingenia Elition S and Ingenia Elition X

Applicant Philips Medical Systems Nederland B.V.

K-Number K173451

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HRS 2018-03-19

PYTHON Plate Trial Instruments

Applicant Treace Medical Concepts, Inc.

K-Number K173930

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NKB 2018-03-19

CapLOX II® / TowerLOX® MIS Pedicle Screw System

Applicant Captiva Spine, Inc.

K-Number K180475

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FRC 2018-03-19

3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H

Applicant 3M Company

K-Number K173437

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QBD 2018-03-19

PrimeStore MTM

Applicant Longhorn Vaccines and Diagnostics, LLC

K-Number DEN170029

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NUJ 2018-03-19

Reprocessed DePuy Mitek Ablation Wand

Applicant Renovo, Inc.

K-Number K173740

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LFD 2018-03-19

Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist

Applicant Syendgen, Inc.

K-Number K173237

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JDG 2018-03-19

Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads

Applicant Stryker Orthopaedics

K-Number K173499

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LOX 2018-03-19

OTW Takeru PTCA Balloon Dilatation Catheter

Applicant KANEKA Corporation

K-Number K172264

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JEC 2018-03-19

Anjon Bremer Halo System

Applicant Anjon Holdings, LLC

K-Number K171863

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GCJ 2018-03-19

Ezee Retrieval

Applicant Genicon, Inc.

K-Number K180579

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DQX 2018-03-19

Double Flexible Tip Wire Guides

Applicant Cook Incorporated

K-Number K171912

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